ArticleTherapeutic advances in medical oncology2026
Lorlatinib-specific outcomes by timing of lorlatinib initiation in advanced ALK-positive non-small cell lung cancer: A retrospective cohort study.
Article in Therapeutic advances in medical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: The phase III CROWN study established lorlatinib as a standard first-line therapy for advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). In routine practice, it may be used upfront or after a second-generation (2G) ALK tyrosine kinase inhibitor (TKI), but real-world lorlatinib-specific systemic and central nervous system (CNS) outcomes by timing remain inadequately defined. Objectives: To compare lorlatinib-specific progression-free survival (PFS), tumor response, overall survival (OS), CNS-first progression, and safety between 1L lorlatinib and Post-2G lorlatinib. Design: Single-center, retrospective, real-world cohort study. Methods: Consecutive patients with ALK-positive advanced NSCLC who initiated lorlatinib at Zhejiang Cancer Hospital between January 2023 and August 2025 were included, with follow-up updated through June 2026. Patients were classified as first-line lorlatinib (1L lorlatinib) or post-2G ALK TKI lorlatinib (Post-2G lorlatinib). The primary endpoint was lorlatinib-specific PFS from lorlatinib initiation. CNS progression was estimated using competing-risk methods. Results: Among 112 patients, 55 received 1L lorlatinib and 57 received Post-2G lorlatinib. Median lorlatinib-specific PFS was not reached versus 13.0 months (hazard ratio [HR], 0.09; 95% confidence interval [CI], 0.04-0.21; P<0.001), and ORR was 92.7% versus 66.7% (P<0.001). CNS-first progression occurred in 0 versus 19 patients; the 36-month cumulative incidence was 0% versus 43.9% (Gray's test P<0.001). Median OS from lorlatinib initiation was not reached versus 28.8 months (HR, 0.22; 95% CI, 0.09-0.53; P<0.001). Lorlatinib-emergent TRAEs were mainly grade 1-2, and permanent discontinuation due to TRAEs was uncommon. Conclusions: Within this lorlatinib-treated cohort, 1L lorlatinib was associated with more favorable lorlatinib-specific systemic, CNS, and survival outcomes than Post-2G lorlatinib. These findings are hypothesis-generating and do not constitute an all-comer comparison of complete first-line treatment strategies.
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